Should the FDA Approve Experimental Treatment for Severe Diseases?
- The study was too small to have persuasive scientific validity.
- The study did not have a proper control group, which further weakened the conclusions.
- The drug may have unknown and serious side-effects. Once the drug is approved, physicians can prescribe it lawfully for a variety of diseases and illnesses, some of which may not be life-threatening.
- Acceding to understandable family demands for premature FDA drug approval will prevent patients from entering larger clinical trials, preferably in a randomized study with a placebo control, where safety and efficacy can be more accurately verified.
- If the FDA weakens its standards for approval for a single drug to respond to a constituency, then be prepared for mission creep to erode standards across the board over time.